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A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434377
Collaborator
(none)
80
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Condition or Disease Intervention/Treatment Phase
  • Other: ergocalciferol supplementation
  • Other: dialysis techniques
  • Other: sunlight exposure time
 N/A

Detailed Description

The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vitamin D supplementation using titration regimen

Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described serum 25(OH)D < 5 ng/ml --> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months serum 25(OH)D 5-15 ng/ml--> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months serum 25(OH)D 16-30 ng/ml--> receive ergocalciferol 50,000 IU monthly for 6 months

Other: ergocalciferol supplementation
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
Other Names:
  • nutritional vitamin D supplementation

    • Other: dialysis techniques
    Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
    Other Names:
  • mode of dialysis

    • Other: sunlight exposure time
    Both groups will be advised to receive similar hours of daily sunlight exposure time.
    Experimental: Vitamin D supplementation using fixed dose regimen

    Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.

    Other: ergocalciferol supplementation
    Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
    Other Names:
  • nutritional vitamin D supplementation

    • Other: dialysis techniques
    Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
    Other Names:
  • mode of dialysis

    • Other: sunlight exposure time
    Both groups will be advised to receive similar hours of daily sunlight exposure time.

    Outcome Measures

    Primary Outcome Measures

    1. proportion of patients with vitamin D adequacy [6 months]

      serum 25(OH)D more than 30 ng/ml

    Secondary Outcome Measures

    1. serum calcium [6 months]

      pre-dialysis serum calcium levels

    2. serum phosphorus [6 months]

      pre-dialysis serum phosphorus levels

    3. serum intact parathyroid hormone [6 months]

      pre-dialysis serum intact parathyroid hormone levels

    4. muscle mass [6 months]

      bioimpedance-derived muscle mass measurement

    5. muscle strength [6 months]

      handgrip strength measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age > 18 years

    • on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months

    • 25(OH)D < 30 ng/ml

    • able to provide inform consent form

    Exclusion Criteria:

    • current ergocalciferol or cholecalciferol treatment

    • known allergy to ergocalciferol

    • active inflammation or infection

    • advanced stage of cancer

    • pregnancy

    • lactation

    • on immunosuppressive drugs or corticosteroids

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    • Principal Investigator: Piyawan Kittiskulnam, Chulalongkorn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piyawan Kittiskulnam, Associate Professor of Medicine, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05434377
    Other Study ID Numbers:
    • 326/65
    First Posted:
    Jun 28, 2022
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Piyawan Kittiskulnam, Associate Professor of Medicine, Chulalongkorn University
    vitamin D insufficiency
    dialysis
    ergocalciferol
    Additional relevant MeSH terms:
    Kidney Failure, Chronic
    Vitamin D Deficiency
    Vitamin D
    Ergocalciferols

    Study Results

    No Results Posted as of Jun 28, 2022